Search Orphan Drug Designations and Approvals
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| Generic Name: | ceritinib |
|---|---|
| Trade Name: | ZYKADIA |
| Date Designated: | 09/27/2013 |
| Orphan Designation: | Treatment of patients with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase(ALK)-positive |
| Orphan Designation Status: | Designated/Approved |
| Marketing Approval Date: | 05/26/2017 |
| Approved Labeled Indication: | Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test |
| Exclusivity End Date: | 05/26/2024 |
| Exclusivity Protected Indication* : | Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test |
| Sponsor: |
Novartis Pharmaceuticals Corp. One Health Plaza East Hanover, New Jersey 07936 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
| Generic Name: | ceritinib |
| Trade Name: | ZYKADIA |
| Date Designated: | 09/27/2013 |
| Orphan Designation: | Treatment of patients with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase(ALK)-positive |
| Orphan Designation Status: | Designated/Approved |
| Marketing Approval Date: | 04/29/2014 |
| Approved Labeled Indication: | ZYKADIA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic nonsmall cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. |
| Exclusivity End Date: | 04/29/2021 |
| Exclusivity Protected Indication* : | Treatment of patients with anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. |
| Sponsor: |
Novartis Pharmaceuticals Corp. One Health Plaza East Hanover, New Jersey 07936 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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